Evaluation of 3TC or FTC Mono-therapy Compared to Continuing HAART as a Bridging Strategy
Status:
Terminated
Trial end date:
2013-05-01
Target enrollment:
Participant gender:
Summary
The purpose of this study was to compare the use of lamivudine (3TC) or emtricitabine (FTC)
alone vs. continuing a failing highly active antiretroviral therapy (HAART) regimen in HIV
infected children, adolescents and young adults. The study was to see if there were changes
in the HIV virus and if there were differences in immune function, viral load and medication
side effects between the two groups over 28 weeks. Participants were assigned to either take
3TC or FTC alone or continue on his/her current failing HAART regimen. During the first 28
weeks of this study, if the participant was randomized to the continue HAART arm, he/she was
not switched to a different or new, potentially suppressive HAART regimen, but continued on
the current failing HAART regimen. However, if continuing HAART, the participant might be
switched to a new regimen if their provider felt that it was clinically needed or the
participant met certain study endpoints (e.g., drop in CD4, increase in viral load).
At the end of 28 weeks, the participant had the choice of remaining on the assigned study
group medication(s) or starting a new HAART regimen prescribed by his/her doctor. Then, they
would be followed for another 24 weeks to compare the difference in immune function, viral
load and medication side effects between the different groups.
Phase:
Phase 4
Details
Lead Sponsor:
International Maternal Pediatric Adolescent AIDS Clinical Trials Group
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) National Institute of Allergy and Infectious Diseases (NIAID)